FDA Adverse Event
Injury
Summary report: N
HS DSP EAR CUR LG SPOON
MDR report key: 3445393
·
Received October 29, 2013
Report
- Report Number
- 2523190-2013-00064
- Event Type
- Injury
- Date Received
- October 29, 2013
- Report Date
- October 29, 2013
- Manufacturer
- INTEGRA YORK, PA INC.
- Product Code
- JZE
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN REC'D FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.
Description of Event or Problem · 1
CUSTOMER INITIALLY REPORTS PTS WERE SCRATCHED IN THE EAR CANAL. DREW A LITTLE BLOOD BUT NO HOSPITALIZATION WAS NEEDED. ON (B)(6) 2013, DOCTOR REPORTS SHE WAS USING DEVICE TO REMOVE EAR WAX FOR WHICH IT WAS INTENDED, CAUSING CUTS IN THE EAR CANAL MUCOSA AT A LIGHTEST TOUCH, WHEN IT IS INTRODUCED TO THE EAR CANAL. IT CAUSED EAR CANAL BLEEDING IN THE 3 PTS I USE IT ON RIGHT AWAY, BEFORE I WAS EVEN ABLE TO GET ANY OF THE WAX OUT. NO HARM BEYOND THE SCRATCH, TREATED WITH ANTIBIOTIC DROPS X BID FOR 3 DAYS. ON (B)(6) 2013... THIS IS PT #2 OF 3 PTS. (SLEE).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 553777 | HS DSP EAR CUR LG SPOON | M11 - ENT | JZE | INTEGRA YORK, PA INC. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |